Potassium dihydrogenorthophosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: no data

Deviations:

not applicable

Principles of method if other than guideline:

The test substance was instilled into the test eyes of 4 New Zealand white rabbits at a dose of 0.1 g. Two rabbits remained unwashed, while the eyes of the remaining rabbits were washed with tap water 20 - 30 sec after treatment. Eyes were assessed for irritation using the method of Draize up to 72 h after instillation.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium dihydrogenorthophosphate

EC Number:

231-913-4

EC Name:

Potassium dihydrogenorthophosphate

Cas Number:

7778-77-0

Molecular formula:

H3O4P.2K

IUPAC Name:

potassium dihydrogen phosphate

Details on test material:

- Name of test material: monopotassium phosphate
- Substance type: solid
- Physical state: white granules
- Analytical purity: > 99 % based on water and insoluble matter
- Lot/batch No.: Reference no. 483B 3114W
- Storage condition of test material: room temperature (stable indefinitely)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Reseach Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: young adult
- Weight at study initiation: 2.53 to 3.09 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71 to 74 ºF
- Humidity (%): 61 %
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye of each rabbit served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per test eye

Duration of treatment / exposure:

The eyes were washed 20 - 30 seconds after instillation for 2 rabbits
The eyes of two rabbits remained unwashed

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: gently washed with 100 mL of tap water at a rate of approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec after instillation of the test substance


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: after 24 h examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: both animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: both animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

other: both animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

other: both animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

1 h after dosing, all eyes exhibited slight chemosis and / or severe discharge. Within 24 h, all irritation had resolved and the test was terminated following the 72 h scoring. Washing the eyes with tap water shortly after exposure had no significant effect on the irritation observed at the 1-h scoring.

Other effects:

All animals remained healthy throughout the study.

Any other information on results incl. tables

The primary irritation indexes for the unwashed and washed eyes at each time interval

Scoring interval	Unwashed	Washed
1 h	8.0	7.0
24 h	0	0
48 h	0	0
72 h	0	0

Eye examination individual eye scores

Animal No.	Cornea	Iris	Conjunctiva
	Opacity/Area	Iritis	Redness	Chemosis	Discharge
1 hour
B5504F	0/0	0	0	1	3
B5506F	0/0	0	0	1	3
B5508F (w)	0/0	0	0	0	3
B5509F (w)	0/0	0	0	1	3
Primary eye irritation index – unwashed 8.0/110, washed 7.0/110.
24 hour
B5504F	0/0	0	0	0	0
B5506F	0/0	0	0	0	0
B5508F (w)	0/0	0	0	0	0
B5509F (w)	0/0	0	0	0	0
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110.
48 hour
B5504F	0/0	0	0	0	0
B5506F	0/0	0	0	0	0
B5508F (w)	0/0	0	0	0	0
B5509F (w)	0/0	0	0	0	0
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110.
72 hour
B5504F	0/0	0	0	0	0
B5506F	0/0	0	0	0	0
B5508F (w)	0/0	0	0	0	0
B5509F (w)	0/0	0	0	0	0
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110.

(w) - washed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Authors conclusion: Under the conditions of this study the test material is non-irritating to both unwashed and washed eyes.

Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted and is therefore submitted as a key study with supporting data also provided to support the conclusions on classification and labelling. Potassium dihydrogenorthophosphate is not considered to be classified for eye irritation in accordance with Regulation (EC) No. 1272/2008 (EU CLP).